Fall Prevention Program for Non-ambulatory Wheeled Mobility Device Users Living With MS
iRoll
Validation of a Fall Prevention Program Among Non-Ambulatory Wheeled Mobility Device Users With Multiple Sclerosis
1 other identifier
interventional
120
1 country
3
Brief Summary
A research study to examine the effectiveness of a fall management program to prevent falls and develop fall recovery strategies for wheeled mobility device users living with Multiple Sclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Mar 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedApril 4, 2019
April 1, 2019
1.8 years
February 27, 2018
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in fall incidence
Fall Diary; Construct: to report and track the number of falls experienced; Less number of falls indicates better outcome.
44 weeks
Secondary Outcomes (3)
Management of Fall
44 weeks
Prevention of Fall
44 weeks
Prevention and Management of Fall
44 weeks
Study Arms (2)
Wait List Control Group
NO INTERVENTIONWait list control group
Fall Management program
EXPERIMENTALIntervention arm
Interventions
Comprehensive fall management program that develops strategies for non-ambulatory wheelchair users living with MS to develpo strategies to recover from a fall.
Eligibility Criteria
You may qualify if:
- Diagnosis of Multiple Sclerosis
- \>18 years old
- Main form of mobility is via a wheeled mobility device (Patient Determined Disease Steps Level 7)
- Self reported ability to transfer with moderate assistance or less
- Self-reported fall history (at least 1 fall/12 months)
You may not qualify if:
- MS exacerbation in the past 30 days
- Received a score of 10 or above to the Short Blessed Test (attached)
- Inability to sit upright for at least 1 hour.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Shepherd Center
Atlanta, Georgia, 30309, United States
UIC
Chicago, Illinois, 60607, United States
UIUC
Urbana, Illinois, 61801, United States
Related Publications (1)
Rice LA, Peterson EW, Backus D, Sung J, Yarnot R, Abou L, Van Denend T, Shen S, Sosnoff JJ. Validation of an individualized reduction of falls intervention program among wheelchair and scooter users with multiple sclerosis. Medicine (Baltimore). 2019 May;98(19):e15418. doi: 10.1097/MD.0000000000015418.
PMID: 31083170DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Rice, PhD,MPT,ATP
Department of Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois at Urbana-Champaign
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2018
First Posted
October 15, 2018
Study Start
March 1, 2018
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
April 4, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share
Individuals participant data will not be available to other researchers.